Product Specification

2019nCov Ag Combo Rapid Test Kit

COVID-19 IgG/IgM Rapid Test is a CE Certified immunochromatographic assay for the qualitative and simultaneous detection of immunoglobulin G and M antibodies against SARS-CoV-2 in human whole blood, serum or plasma specimens. For professional in-vitro use only.

Are you interested in buying our COVID-19 IgG/IgM Rapid Test kit? Please write to info@primahometest.com for further information.

Principle of the Test
The Test is a qualitative membrane based lateral flow immunochromatographic assay for the detection of IgG and IgM antibodies to SARS-CoV-2 Nucleocapsid in whole blood, serum or plasma specimen. The test combines an IgG and an IgM component, corresponding to two lines on the test strip positioned in the test cassette. During testing anti-SARS-CoV-2 IgG and IgM possibly present in the specimen react with the reagents and the nanoparticles present in the test. The mixture chromatographically migrates upward by capillary action interacting with the two test line regions resulting in the appearance of a coloured line, if the specimen contains IgM and/or IgG antibodies to SARS-CoV-2 Nucleocapsid. If antibodies are not present in the specimen, no coloured line will appear in either test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the Control (C) line region, indicating that the test procedure has been performed properly and that test components have operated as intended.

COVID-19 IgG/IgM Rapid Test is dedicated to healthcare professionals with the aim to support them in the COVID-19 emergency management, receiving quick answers about the health status of their patients:
- high Sensitivity and Specificity standards, when compared to a PCR Methodology;
- safe and accurate results in just 10 minutes;
- easy to use and to read.

MATERIALS AND COMPONENTS

Materials provided with the test

Materials required but not provided

• Timer

STORAGE AND STABILITY

• Store the test as packaged between 2-30°C.
• The Test stable until the expiration date printed on the outer packing, the product will be expired after 24 months.
• Do not use beyond the expiration date.
• Do not freeze any contents of the test
• The test must remain in the sealed pouch until use.

TEST PROCEDURE

Before test, please read the instructions carefully.

• Take the cassette to equilibrate to room temperature.
• Unpack the aluminum foil bag, take out the cassette.
• Insert the absorber end of the cassette into mouth. Make sure cassette is horizontal statement.

• Actively swab the inside of the mouth and tongue to collect oral fluid.
• Remove the absorber end from the mouth when the purple color move across the result window in the center of the test device.
• Wait for 10 minutes and read the results.

NOTE:

*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.

*Do not eat, drink, or smoke prior to the test for at least 30 Minutes.

*Any saliva specimen is appropriate for testing but the saliva specimen collected in the morning, before mouth rinsed, eating or drinking, is recommended

INTERPRETATION OF TEST RESULTS

This product can only perform qualitative analysis on the detection object.

Positive Result:

If both C and T lines are visible within 10 minutes, the test result is positive and valid.

Negative Result:

If test area (T line) has no color and the control area displays a colored line, the result is negative and valid

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test.

INTERNAL CONTROL

The test contains a built-in internal control in the test card. A color band appearing in the control region (C) is designed as an internal control. The appearance of the control line confirms that sufficient flow has occurred, and that the test card is working normally. If the control line does not appear within 10 minutes, it is considered an error in the test result and it is recommended to test again with the same sample and a new device.

LIMITATIONS

• The result of the test should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiological information, and further clinical data.
• The Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.

• The test must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect
• A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
• Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
• React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.
• Positive test results do not rule out co-infections with other pathogens.
• Negative test results are not intended to rule in other viral or bacterial infections.
• Negative results should be treated as presumptive and confirmed with a molecular assay.
• Clinical performance was evaluated with fresh samples.
• Users should test specimens as quickly as possible after specimen collection.

PERFORMANCE CHARACTERISTIC

1. Clinical Verification

The performance of Test was established with 232 sample collected from symptomatic patients, who with symptoms onset within 7 days.

Positive results broken down by CT value:

2. Limit of Detection

The experimental results show that for the virus culture concentration above 100 TCID50/mL, the positive rate of detection is greater than or equal to 95%. For the virus culture concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So, the limit of detection of the Test Card is 100 TCID50/mL.

3. Cross-reactivity

4. Interference Substances

The test results do not be interfered with the substance at the following concentration:

5. Precision

1. Test 10 replicates of negative and positive by using the reference materials of enterprises. The negative agreement and the positive agreement were 100%.

2. Test three different lots kits including positive and negative reference materials of enterprises. The negative results and the positive results were 100%

6. Hook Effect

The Test Card was tested up to 1.6 × 105 TCID50/ml of heat-inactivated 2019-nCoV strain and no high-dose effect was observed.

PRECAUTIONS

• For in vitro diagnostic use.
• Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used test contents.
• Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.
• Do not reuse the used Test Card or saliva swab.
• Should never open the foil pouch of the Test Card exposing it to the ambient environment until the Test Card is ready for immediate use.
• Discard and do not use any damaged or dropped Test Card or material.
• Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
• Sample collection and handling procedures require specific training and guidance.
• To obtain accurate results, do not use visually bloody or overly viscous samples.
• To obtain accurate results, an opened and exposed Test Card should not be used.
• Testing should be performed in an area with adequate ventilation.
• Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this test.
• Wash hands thoroughly after handling.

KEY TO SYMBOLS USED

		Materials Included			Test Cassette
		Instructions for Use			Date of
					Manufacturer
		Consult Instructions			Do Not Reuse
		For Use
		Store at 2°C~30°C			Catalogue Number
		Expiration Date			Keep away from Sunlight
		Manufacturer			Tests per Kit
		Lot Number			In Vitro Diagnostic Medical Device
		Keep Dry
		Guangzhou Decheng Biotechnology Co., LTD
		Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China
		TEL:+86-020-82557192
		sales@dochekbio.com
		www.dochekbio.com
	CMC Medical Devices & Drugs S.L.
	C/ Horacio Lengo Nº 18, CP 29006,
	Málaga, Spain